Symptomtext
patient received an expired dose of ACT-HIB with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves 4 years old male patient who received an expired dose of haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Immunisation; and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (Quadracel) for Immunisation. On 11-Oct-2023, the patient received a standard expired dose 3 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml (lot UJ798AA) (with an unknown strength and expiry date) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller asked Is the dose okay or do it need to be repeated? Action taken was not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.